Precise Treatment Table™

GUDID 05060191071086

Precise Treatment Table

ELEKTA LIMITED

Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered Therapeutic x-ray system table, powered

• Primary Device ID: 05060191071086
• NIH Device Record Key: de88c0c1-3d7b-4b75-90c8-5c52bb166daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise Treatment Table™
• Version Model Number: 1526779
• Company DUNS: 525557559
• Company Name: ELEKTA LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983678

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ELEKTA LIMITED

• 05060191071468 - Elekta Unity: 2021-12-08 CT OVERLAY
• 05060191071482 - Elekta Unity: 2021-12-08 Indexing Bar
• 05060191071499 - Elekta Unity: 2021-12-08 Indexing Bars
• 05060191071598 - Elekta Unity: 2021-12-08 Elekta Unity
• 05060191071345 - Integrity™: 2020-01-20 Integrity
• 05060191071420 - Elekta Unity: 2019-05-08 INDEXING BAR
• 05060191071437 - Elekta Unity: 2019-05-08 INDEXING BARS
• 05060191071321 - Elekta Unity: 2019-02-25 Elekta Unity